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2017-43271

2017-43271

Title 
Start-Up Lead
Job Locations 
-
Singapore
Taiwan-Taipei
Korea, South-Seoul
Thailand
Philippines
China-Hong Kong
Malaysia
Australia-Sydney
Posted Date 
10/4/2017

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community. 

Responsibilities

As a Start Up Lead you will be working as part of Clinical Operations team and you will be responsible for all aspects of Start Up activities at the regional level to achieve quick and successful activation of sites in accordance with ICH GCP, FDA regulations, applicable regulations and requirements, and SOPs.

 

You will be working on a wide spectrum of projects in phase I-IV research at both GP practices and hospitals.

 

Responsibilities will include:

  • Using the start-up methodology to drive early and predictable site activations through oversight of all SSU activities, driving delivery and compliance across the assigned region
  • Coordinate study start up activities, coaching and mentoring as appropriate
  • Working collaboratively with functional colleagues and sponsors to ensure successful completion of study start up
  • Eliminating all potential causes of delay
  • Overseeing compliance and reporting progress

Qualifications

To be considered for the Start Up Lead (SUL) position, you will have an undergraduate degree (or equivalent) in clinical science or health related field or be a licensed health care professional. Experience managing Start Up activities and managing and meeting targets on deliverables during the start-up process is essential. 


You must have a thorough knowledge of ICH GCP and local regulatory authority regulations regarding drug research. You must also be a competent user of computerized information systems including MS Office and CTMS. 

 

Fluency in English and local language is required.

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